The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient's physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate.

For measuring ECG, SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intent population is all types of people including newborn, pediatric and adult.

The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

Device Description

The BW-X07HD Handheld VitalSigns Monitoring System is a handheld, smart and wireless connected medical device. The device can be easily used by healthcare professional personnel, ordinary users or patients, to monitor multiple physiological indexes, including TEMP, ECG, NIBP and SpO2 as well as the pulse rate. Medical data can be stored locally and can be sent through WiFi, 3G or 4G network.

The device incorporates an embedded system and an Android application. The embedded system integrates the Temp module, the ECG, NIBP, SpO2 module and the wireless module together. The device allows users to communicate through an HD video conferencing system but cannot be used as phone (only IP connection, Micro SIM card for data transmission).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes the device, a Handheld Vital Signs Monitoring System, Model: BW-X07HD, and its performance characteristics compared to a predicate device (ViSi Mobile Monitoring System K150361). The acceptance criteria are largely defined by compliance with recognized international standards for medical electrical equipment and specific vital sign monitoring devices, as well as meeting performance specifications.

Due to the format of the provided text, a direct "acceptance criteria" column with explicit pass/fail values isn't present in a table. Instead, the document discusses compliance with standards and the device's technical specifications. The "Reported Device Performance" below is extracted from the "Subject Device BW-X07HD" column in the comparison table within the 510(k) summary. The "Acceptance Criteria" are implied by the standards the device complies with, which define the required performance levels.

Parameter/Function	Implied Acceptance Criteria (Standard Compliance)	Reported Device Performance (BW-X07HD)
Intended Use/Indications for Use	Consistent with predicate device, considering expanded patient population and usage environment with demonstrated safety/effectiveness.	Monitors ECG, SpO2, NIBP, TEMP, pulse rate in hospital, clinic, homecare, home. Collects, stores, transmits patient health info.
Product Code	Same as predicate device (MWI, DRT, DXN, FLL, DQA).	MWI, DRT, DXN, FLL, DQA
Patient Population (Temp)	Clinical validation for all types (newborn, pediatric, adult).	All types of people (newborn, pediatric, adult)
Patient Population (NIBP)	Clinical validation for pediatric (3+ years) and adult.	Both pediatric (3+ years) and adult
Patient Population (ECG, SpO2)	Adult	Adult
Usage Environment	Compliance with IEC 60601-1-2, IEC 60601-1-11 for operation temperature, humidity, water-proof, EMC in broader environments (home and hospital).	Home and hospital
Power Supply (Li-polymer battery capacity)	Compliance with IEC62133 requirements.	3.7V/2500mAh
Power Supply (Li-polymer battery performance capacity)	N/A (Predicate >12hrs, Subject 4hrs - difference noted but not explicitly criteria)	4 hours
ECG Function (Measuring Mode)	N/A (Difference in leads compared to predicate)	5 Electrodes, 7-Lead ECG
ECG Function (DC offset Voltage Range)	±300mV (matching predicate)	±300mV
ECG Function (Differential Voltage Measurement Range)	±5mV (matching predicate)	±5mV
ECG Function (Resolution)	1bpm (matching predicate)	1bpm
NIBP Function (Principle of Operation)	Oscillation (matching predicate)	Oscillation
NIBP Function (Measurement Range)	N/A (Broader than predicate)	Adult & Pediatric: 0-295mmHg (0-39.3kPa)
NIBP Function (Accuracy)	Compliance with ISO 81060-2:2013 (clinical test).	±3mmHg (±0.4kPa)
NIBP Function (Pressure Resolution)	1mmHg (matching predicate)	1mmHg
NIBP Function (Pulse Rate Measuring Range)	N/A (Different from predicate)	40 bpm to 180 bpm
NIBP Function (Pulse Rate Accuracy)	±3 bpm (matching predicate)	±3 bpm
NIBP Function (Pulse Rate Resolution)	1 bpm (matching predicate)	1 bpm
SpO2 Function (Principle of Operation)	Lambert Beer Law (implied same as predicate type)	Lambert Beer Law
SpO2 Function (Measurement Range)	N/A (Broader than predicate)	0~100%
SpO2 Function (Accuracy)	Compliance with ISO 80601-2-61:2011 (clinical test).	Adult ±2 % (70% to 100% SpO2), Undefined (0 to 69% SpO2)
SpO2 Function (Resolution)	1% (matching predicate)	1%
SpO2 Function (Pulse Rate Measuring Range)	N/A (Different from predicate)	25 bpm to 250 bpm
SpO2 Function (Pulse Rate Accuracy)	±3 bpm (matching predicate)	±3 bpm
SpO2 Function (Pulse Rate Resolution)	1 bpm (matching predicate)	1 bpm
Temperature Function (Principle of Operation)	Infrared red (matching predicate)	Infrared red
Temperature Function (Measurement Range)	N/A (Different from predicate)	Body: 32.0°C~~43.0°C / 89°F~~109.4°F; Room: 0°C~~50°C / 32°F~~122°F; Surface: 0°C~~90°C / 32°F~~194°F
Temperature Function (Accuracy)	Compliance with ISO 80601-2-56:2009 (clinical test).	Body: +/- 0.2°C (35°C-42°C), +/-0.3°C (32°C-34.9°C, 42.1°C-43°C); Surface: +/- 0.2°C (22°C-40°C); Others +/-2°C
Temperature Function (Resolution)	0.1°C / 0.1°F (matching predicate)	0.1°C / 0.1°F
EMC/Electrical Safety	Compliance with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-2-49:2011, IEC 60601-2-27:2011, others.	All testing results are PASS.
Biocompatibility	Compliance with ISO 10993-5:2009, ISO 10993-10:2010.	All testing results are PASS.
Wireless Coexistence & Cybersecurity	Evaluated (no specific standard mentioned, but implies testing)	Evaluated.

Study Details

The document refers to "clinical tests" for NIBP, Oximeter (SpO2), and Thermometer, and states that their results meet the requirements of the respective ISO standards. It does not provide detailed descriptions of these clinical studies (e.g., protocols, specific methodologies, explicit sample sizes beyond "participants," or granular results).

Sample size used for the test set and the data provenance:
- NIBP: "clinical test of NIBP was provided including both adult participants and pediatric participants aged more than 3 years old." (Specific number of participants not stated).
- Thermometer: "clinical test of TEMP was provided including all types of people including newborn, pediatric and adult." (Specific number of participants not stated).
- Oximeter: "clinical results of Oximeter Part of subject device meet the requirement as described in ISO 80601-2-61:2011." (Specific number of participants not stated, but this standard specifies that studies should be performed on at least 10 healthy adult volunteers, with a stable arterial oxygen saturation range between 70% and 100%).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the reference to "clinical investigation" suggests prospective data collection for the purpose of the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For vital signs monitoring devices, ground truth is typically established by reference devices (e.g., invasive blood pressure monitoring for NIBP, blood gas analysis for SpO2, and calibrated thermometers for temperature) rather than expert consensus on interpretation. The document mentions compliance with standards that dictate how ground truth is established for these measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly mentioned. For vital signs performance studies, expert adjudication methods like 2+1 or 3+1 are generally not applicable because the "ground truth" is measured instrumentally rather than being a subjective interpretation by experts.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool where human readers' performance with and without AI would be evaluated.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The clinical tests for NIBP, SpO2, and Thermometer evaluate the device's standalone performance in measuring these vital signs against reference methods. While a human is involved in applying the device and reading its output, the intrinsic measurement accuracy being evaluated is of the device itself (analogous to "algorithm only" in the context of a straightforward measurement device). The performance is assessed against recognized ISO standards without explicitly stating a human-in-the-loop component for improving diagnostic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference Devices/Methods calibrated to medical standards:
  - For NIBP, the ground truth is established by a reference method as per ISO 81060-2:2013 (which generally involves simultaneous invasive or oscillometric reference measurements).
  - For SpO2, the ground truth is established by fractional oxygen saturation measurements from co-oximetry of arterial blood samples as per ISO 80601-2-61:2011.
  - For Temperature, the ground truth is established by a reference method as per ISO 80601-2-56:2009 (typically involving a highly accurate contact thermometer).
The sample size for the training set:
- The document does not refer to a training set in the context of machine learning or AI. This is a conventional vital signs monitoring device, and its performance is validated through clinical testing against established standards, not via a machine learning training/testing paradigm.
How the ground truth for the training set was established:
- As there is no mention of a training set for machine learning, this information is not applicable/provided.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue and white.

December 17, 2018

Visiomed Technology Co., Ltd. % Filed Fu Consultant Shenzhen Joyantech Consulting Co., Ltd 1122#, International Mayor Communication Center, Baishizhong Road 55# Nanshan District, Shenzhen, 518000 CN

Re: K172965

Trade/Device Name: Handheld Vital Signs Monitoring System, Model: BW-X07HD Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DRT, DXN, DOA, FLL Dated: January 2, 2018 Received: January 19, 2018

Dear Filed Fu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Stephen C. Browning -S5

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172965

Device Name

Handheld VitalSigns Monitoring System, Model: BW-X07HD

Indications for Use (Describe)

The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Submission Date	2017-12-24
Manufacturerinformation	Submitter's Name: Visiomed Technology Co.,LtdAddress: 2 Floor of No.1 Building, Jia An TechnologicalIndustial Park, 67 Distric,Bao An, Shenzhen,Guangdong,ChinaContact person: Chen XiaoFengTEL: 0755-29481701-103FAX: 0755-29481705E-Mail: jay@visiomed-tech.com
	SubmissionCorrespondent
Image: Logo

Establishmentregistration number	3012429388

2. Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Handheld VitalSigns Monitoring System
Model:	BW-X07HD
Classification name:	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Review Panel:	Cardiovascular
Product Code:	Product Code: MWISubsequent Product Codes: DRT, DXN, DQA, FLL
Device Class:	2
Regulation Number:	870.2300

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3. Predicate Device Information

Sotera Wireless, Inc. Sponsor: Device: ViSi Mobile Monitoring System K150361 510(K) Number:

4. Device Description

5. Intended Use/Indications for Use

For measuring ECG, SPO2 the intended patient population is adult, for measuring SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intended patient population is all types of people including newborn, pediatric and adult.

The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

Item	Subject DeviceBW-X07HD	Predicate DeviceK150361	Remark
IntendedUse/Indicationfor Use	TheBW-X07HD Handheld VitalSignsMonitoring System is intended to be used inhospital, clinic, homecare, home and othermedical settings where patient care isoffered by qualified healthcare personnelwho can use the device to monitor thepatient's physical indexes, including ECG,SpO2, NIBP and TEMP as well as the pulserate.For measuring ECG, SpO2 the intendedpatient population is adult, for measuringSpO2 the intended patient population isadult, for measuring NIBP the intendedpatient population is both adult andpediatric aged more than 3 years old,whereas for measuring TEMP the intendedpatient population is all types of peopleincluding newborn, pediatric and adult. Thedevice is used to collect, store, and transmitgeneral patient health information and	The ViSi Mobile Monitoring System islintended for use by clinicians andmedically qualified personnel for singleor multi-parameter vitalsiansmonitoring of adult patients (18 years orolder). It is indicated for ECG (3 or 5lead-wire), respiration rate (RESP),heart rate (HR), noninvasive blood(NIBP),pressurenoninvasive blood pressure (cNIBP),Inoninvasive monitoring of functionaloxygen saturationof arterialhemoglobin (SpO2), pulse rate (PR),and skin temperature (TEMP) inhospital-based facilities; including,medical-surgicalgeneralfloors.lintermediate care floors,andemergency departments. The ViSiMobile Monitoring System may be usedas standalone devices or networked to	Similar (Note 01)
Item	Subject DeviceBW-X07HD	Predicate DeviceK150361	Remark
	patient vital signs data between the patientand a health care professional.	ViSi Mobile Remote Viewers throughwireless 802.11 communications.
Product Code	MWI, DRT, DXN, FLL, DQA	MWI, DRT, DXN, FLL, DQA	Same
Patientpopulation	The intended patient population formeasuring Temp is all types of peopleincluding newborn, pediatric and adult,whereas, for measuring NIBP is bothpediatric and adult, for measuring ECG isadult and SpO2 is adult.	Adults ≥ 18 years	Different (Note02)
UsageEnvironment	home and hospital	Hospital-based facility includingemergency departments, generalmedical-surgical and intermediate carefloors.	Similar (Note 03)
Power Supply
Internalsupply	TypeRechargeable Li-polymerbattery	Rechargeable Li-polymer battery
	Capacity3.7V/2500mAh	3.7 V/2000 mAh	Similar (Note 04)
	Performancecapacity4 hours	> 12 hours
AC-DC Powersupply	Line Voltage100Vac to 240Vac	100Vac to 240Vac
	Currentless than 0.5A rms. at 90Vacinput and maximum load	/	SE
	Frequency50Hz or 60Hz	50Hz or 60Hz
ECG Function
		3-wire: II
	Measuring Mode5 Electrodes, 7-Lead ECG	5-wire: I, II, III, AVL, AVR, AVF, V
	DC offset Voltage Range±300mV	±300mV	SE
	Differential VoltageMeasurement Range±5mV	±5mV
	Resolution1bpm	1bpm	Same
NIBP Function:
	Principle ofOperation	oscillation	Same
BloodPressure	MeasurementRangeAdult & Pediatric:0-295mmHg (0-39.3kPa)	Systolic Range: 60 to 240 mmHgDiastolic Range: 40 to 160 mmHg
	Accuracy±3mmHg (±0.4kPa)	Mean error of less than ± 5 mmHgand a std. dev. of ≤ 8 mmHg	Similar (Note 05)
	PressureResolution1mmHg	1mmHg
Pulse Rate	MeasuringRange40 bpm to 180 bpm	30 to 240 BPM
	Accuracy±3 bpm	±3 BPM
	Resolution1 bpm	1 BPM
SpO2 Function
	Principle of OperationLambert Beer Law		Same
SpO2	Measurement Range0~100%	49 to 100%	Similar (Note 06)
Item	Subject DeviceBW-X07HD	Predicate DeviceK150361	Remark
Pulse Rate	Accuracy	Adult ±2 %(70% to 100% SpO2),Undefined (0 to 69% SpO2);	≤ 2% from 70-100% (no motion)Unspecified from 49-69%
	Resolution	1%	1%
	Measuring Range	25 bpm to 250 bpm	30 to 240 BPM
	Accuracy	±3 bpm	≤ 3 BPM
	Resolution	1 bpm	1 BPM
Temperature Function
Principle of Operation		Infrared red		Same
Measurement Range	Body temperature: 32.0°C~~43.0°C / 89°F~~109.4°FRoom temperature: 0°C~~50°C / 32°F~~122°FSurface temperature: 0°C~~90°C / 32°F~~194°F	0 ~ 19.9 (32 ~ 67.9 ) ±0.3 (±0.5 )20 ~ 24.9 (68 ~ 76.9 ) ±0.3 (±0.5 )25 ~ 35.9 (77 ~ 96.7 ) ±0.2 (±0.3 )36 ~ 39.9 (96.8 ~ 103.9 )±0.1 (±0.2 )40 ~41.9 (104 ~ 107.5 )±0.2 (±0.3 )42 ~ 50.0 (107.6 ~ 122 )±0.3 (±0.5 )
Accuracy (not including sensor)	+/- 0.2°C (35°C-42°C) / +/- 0.2°F (95°F-107.6°F) in body temperature+/-0.3°C (32°C-34.9°C, 42.1°C-43°C) / +/- 0.3°F (89.6°F-93.2°F, 107.6°F-109.4°F) in body temperature.+/- 0.2°C (22°C-40°C) / +/- 0.2°F (71,6°F-104°F);Others +/-2°C / +/-2°F in surface temperature.			Similar (Note 07)
Resolution	0.1°C / 0.1°F	0.1°C / 0.1°F
Average Time Constant	1~2s	< 6 min (25 ~37 (77 ~98.6 ))

6. SE Comparison

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Version: B/0

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Version: B/0

Note 01:

In the Intended Use/Indication for Use, the measuring function range (measuring ECG, TEMP, SPO2, NIBP) of the Subject Device is smaller than the predicated device which is measuring ECG, RESP, TEMP, SPO2 and NIBP.

The use environment of the subject device is broader than the predicated device. The concern from environment difference lay on the user conditions such as operation temperature, humidity, water-proof and electromagnetic compatibility items, etc. But the subject device was tested according to IEC 60601-1-2, IEC 606061-1-11 and the other standards, and all the testing results are PASS.

The use population of the subject device is broader than the predicated device, but the clinical test of NIBP was provided including both adult participants and pediatric participants aged more than 3 years old and the clinical test of TEMP was provided including all types of people including newborn, pediatric and adult from the different use population.

The wireless data transmission is different from the predicate device. The subject device uses WIFI, 3G and Bluetooth. All the performances including wireless coexistence and cybersecurity has evaluated.

All concerns from the differences were resolved. There were raise no safety and effective issues from the differences.

Note 02: The patient population of subject device is broader than the range of the Predicate Device. But the subject device has passed the clinical validation for the relative population. The clinical test of NIBP was provided including both adult participants and pediatric participants aged more than 3 years old and the clinical test of TEMP was provided including all types of people including newborn, pediatric and adult. The clinical tests are passed.

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Visiomed Technology Co., Ltd

Product: Handheld VitalSigns Monitoring System

Note 03: As the Note 01, the usage environment of subject device is broader than the predicate device. The concern from environment difference lay on the user conditions such as operation temperature, humidity, water-proof and electromagnetic compatibility items, etc. The subject device was tested according to IEC 60601-1-2, IEC 606061-1-11 and the other standards, and all the testing results are PASS, the concerns mentioned previously were resolved.

Note 04: The specification of Li-polymer battery is a little different between subject device especailly for the capacity. But the subject device has complied with IEC62133 requirements.

Note 05: The NIBP parameter is a little different between subject device and predicate device. But the subject device has complied with the latest standard IEC 80601-2-30. ISO 81060-2 clinical test.

Note 06: The SpO2 parameter is a little different between subject device and predicate device. But the subject device has complied with the latest standard IEC 60601-2-61 and the clinical test according to the FDA guidance.

Note 07: The Temp parameter is a little different between subject device and predicate device. But the subject device has complied with the latest standard IEC 60601-2-56 and the clinical test.

7. Nonclinical Tests

The subject device conforms to the following standards:

� IEC 60601-1:2005+A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance

� IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General

Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.

& ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity:

& ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;

� IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

� IEC 60601-2-27:2011 Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment

� IEC 80601-2-30: 2013 Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers

� ISO 81060-2:2013 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type

� ISO 80601-2-61:2011 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment

� ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

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8. Clinical Tests

In this submission, the clinical reports of NIBP, Oximeter and Thermometer were provided.

The clinical results of Oximeter Part of subject device meet the requirement as described in ISO 80601-2-61:2011. Besides, no AE or side-effect occurs during the clinical investigation.

The clinical results of NIBP part of subject device meet the requirement as described in ISO 81060-2:2013. Besides, no AE or side-effect occurs during the clinical investigation.

The clinical results of Thermometer Part of the subject device meet the requirement as described in ISO 80601-2-56:2009. Besides, no AE or side-effect occurs during the clinical investigation.

9. Other information (such as required by FDA guidance)

No other information.

10. Conclusions

The subject device: Handheld VitalSigns Monitoring System, BW-X07HD is substantially equivalent to the predicate device: ViSi Mobile Monitoring System manufactured by Sotera Wireless, Inc.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).